Trial Outcomes & Findings for Glutamine for the Treatment of Patients With Irritable Bowel Syndrome (NCT NCT01414244)

Results Overview

The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

106 participants

Primary outcome timeframe

baseline and 8 weeks following therapy

Results posted on

2017-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	Glutamine Oral Glutamine Powder	Placebo Oral Whey Protein Powder
Overall Study STARTED	54	52
Overall Study COMPLETED	54	52
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glutamine for the Treatment of Patients With Irritable Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glutamine n=54 Participants Oral Glutamine Powder	Placebo n=52 Participants Oral Whey Protein Powder	Total n=106 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 9.5 • n=5 Participants	30.9 years STANDARD_DEVIATION 7.1 • n=7 Participants	31.7 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	54 Participants n=5 Participants	52 Participants n=7 Participants	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks following therapy

The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response.

Outcome measures

Outcome measures
Measure	Glutamine n=54 Participants Oral Glutamine Powder	Placebo n=52 Participants Oral Whey Protein Powder
Change in the Irritable Bowel Symptom Severity Scale	181 units on a scale Standard Deviation 48	301 units on a scale Standard Deviation 57

SECONDARY outcome

Timeframe: baseline and 8 weeks following therapy

The secondary outcome measure will be a change in intestinal permeability from baseline to 8 weeks at the conclusion of therapy. Intestinal permeability is measured by the urinary lactulose/mannitol ratio following ingestion of a solution of lactulose and mannitol.

Outcome measures

Outcome measures
Measure	Glutamine n=54 Participants Oral Glutamine Powder	Placebo n=52 Participants Oral Whey Protein Powder
Intestinal Permeability	0.05 lactulose/mannitol (L/M) Standard Deviation 0.01	0.10 lactulose/mannitol (L/M) Standard Deviation 0.03

SECONDARY outcome

Timeframe: Baseline and 8 weeks following therapy

Baseline and 8 week at the conclusion of therapy

Outcome measures

Outcome measures
Measure	Glutamine n=54 Participants Oral Glutamine Powder	Placebo n=52 Participants Oral Whey Protein Powder
Stool Frequency	2.9 stools per day Standard Deviation 0.9	5.3 stools per day Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline and 8 weeks following therapy

Bristol Stool Scale The Bristol Stool Scale characterizes stool characteristics and ranges from a minimum score of 1 with depicts hard or constipated stool to a maximum score of 7 which is watery or diarrheal stools. In this trial, stool that is less than 7 is better and depicts a good outcome.

Outcome measures

Outcome measures
Measure	Glutamine n=54 Participants Oral Glutamine Powder	Placebo n=52 Participants Oral Whey Protein Powder
Stool Consistency	3.9 units on a scale (1-7) Standard Deviation 1.2	6.6 units on a scale (1-7) Standard Deviation 0.53

Adverse Events

Glutamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

QiQi Zhou

Tulane University

Phone: 988-7800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place